Invanz Side Effects
Generic Name: ertapenem
Please note - some side effects for Invanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Invanz - for the Consumer
Invanz
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Invanz:
Seek medical attention right away if any of these SEVERE side effects occur when using Invanz:Diarrhea; dizziness; headache; indigestion; nausea; sleeplessness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; breathing problems; chest pain; fast heartbeat; fever, chills, or sore throat; mental or mood changes (eg, agitation, anxiety, confusion); pain, swelling, or redness at the injection site; seizures; severe or persistent diarrhea; severe stomach cramps or pain; swelling of hands or feet; tremors or abnormal muscle movements; unusual vaginal odor or discharge; white patches in the mouth.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopInvanz Side Effects - for the Professional
Invanz
The following are described in greater detail in the Warnings and Precautions section.
- Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
- Seizure Potential [see Warnings and Precautions (5.2)]
- Interaction with Valproic Acid [see Warnings and Precautions (5.3)]
- Clostridium difficile-Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4)]
- Caution with Intramuscular Administration [see Warnings and Precautions (5.5)]
- Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6)]
- Laboratory Tests [see Warnings and Precautions (5.7)]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults Receiving Invanz as a Treatment Regimen
Clinical trials enrolled 1954 patients treated with Invanz; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies (14)]. Most adverse experiences reported in these clinical trials were described as mild to moderate in severity. Invanz was discontinued due to adverse experiences in 4.7% of patients. Table 3 shows the incidence of adverse experiences reported in ≥2.0% of patients in these trials. The most common drug-related adverse experiences in patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%).
| Invanz* 1 g daily |
Piperacillin/ Tazobactam* 3.375 g q6h |
Invanz† 1 g daily |
Ceftriaxone† 1 or 2 g daily |
|
| Adverse Events | (N=802) | (N=774) | (N=1152) | (N=942) |
|
||||
| Local: | ||||
| Infused vein complication | 7.1 | 7.9 | 5.4 | 6.7 |
| Systemic: | ||||
| Death | 2.5 | 1.6 | 1.3 | 1.6 |
| Edema/swelling | 3.4 | 2.5 | 2.9 | 3.3 |
| Fever | 5.0 | 6.6 | 2.3 | 3.4 |
| Abdominal pain | 3.6 | 4.8 | 4.3 | 3.9 |
| Hypotension | 2.0 | 1.4 | 1.0 | 1.2 |
| Constipation | 4.0 | 5.4 | 3.3 | 3.1 |
| Diarrhea | 10.3 | 12.1 | 9.2 | 9.8 |
| Nausea | 8.5 | 8.7 | 6.4 | 7.4 |
| Vomiting | 3.7 | 5.3 | 4.0 | 4.0 |
| Altered mental status‡ | 5.1 | 3.4 | 3.3 | 2.5 |
| Dizziness | 2.1 | 3.0 | 1.5 | 2.1 |
| Headache | 5.6 | 5.4 | 6.8 | 6.9 |
| Insomnia | 3.2 | 5.2 | 3.0 | 4.1 |
| Dyspnea | 2.6 | 1.8 | 1.0 | 2.4 |
| Pruritus | 2.0 | 2.6 | 1.0 | 1.9 |
| Rash | 2.5 | 3.1 | 2.3 | 1.5 |
| Vaginitis | 1.4 | 1.0 | 3.3 | 3.7 |
In patients treated for complicated intra-abdominal infections, death occurred in 4.7% (15/316) of patients receiving Invanz and 2.6% (8/307) of patients receiving comparator drug. These deaths occurred in patients with significant co-morbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators.
In clinical trials, seizure was reported during study therapy plus 14-day follow-up period in 0.5% of patients treated with Invanz, 0.3% of patients treated with piperacillin/tazobactam and 0% of patients treated with ceftriaxone [see Warnings and Precautions (5.2)].
Additional adverse experiences that were reported with Invanz with an incidence >0.1% within each body system are listed below
Body as a Whole: abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, asthenia/fatigue, necrosis, candidiasis, weight loss, facial edema, injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis, flank pain, syncope
Cardiovascular System: heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage
Digestive System: acid regurgitation, oral candidiasis, dyspepsia, gastrointestinal hemorrhage, anorexia, flatulence, C. difficile-associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis
Musculoskeletal System: leg pain
Nervous System & Psychiatric: anxiety, nervousness, seizure [see Warnings and Precautions (5.2)], tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo
Respiratory System: cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance
Skin & Skin Appendage: erythema, sweating, dermatitis, desquamation, flushing, urticaria
Special Senses: taste perversion
Urogenital System: renal impairment, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Invanz, the adverse experience profile was generally similar to that seen in previous clinical trials.
Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery
In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Invanz 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall adverse experience profile was generally comparable to that observed for Invanz in previous clinical trials. Table 4 shows the incidence of adverse experiences other than those previously described above for Invanz that were reported regardless of causality in ≥2.0% of patients in this trial.
| Adverse Events | Invanz 1 g (N = 476) |
Cefotetan 2 g (N = 476) |
| Anemia | 5.7 | 6.9 |
| Small intestinal obstruction | 2.1 | 1.9 |
| Pneumonia | 2.1 | 4.0 |
| Postoperative infection | 2.3 | 4.0 |
| Urinary tract infection | 3.8 | 5.5 |
| Wound infection | 6.5 | 12.4 |
| Wound complication | 2.9 | 2.3 |
| Atelectasis | 3.4 | 1.9 |
Additional adverse experiences that were reported in this prophylaxis trial with Invanz, regardless of causality, with an incidence >0.5% within each body system are listed below:
Gastrointestinal Disorders:C. difficile infection or colitis, dry mouth, hematochezia
General Disorders and Administration Site Condition: crepitations
Infections and Infestations: cellulitis, abdominal abscess, fungal rash, pelvic abscess
Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion
Musculoskeletal and Connective Tissue Disorders: muscle spasms
Nervous System Disorders: cerebrovascular accident
Renal and Urinary Disorders: dysuria, pollakiuria
Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.
Pediatric Patients Receiving Invanz as a Treatment Regimen
Clinical trials enrolled 384 patients treated with Invanz; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies (14)]. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 shows the incidence of adverse experiences reported in ≥2.0% of pediatric patients in clinical trials. The most common drug-related adverse experiences in pediatric patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), vomiting (2.1%).
| Invanz*,† | Ceftriaxone* | Ticarcillin/ Clavulanate† | |
| Adverse Events | (N=384) | (N=100) | (N=24) |
|
|||
| Local: | |||
| Infusion Site Erythema | 3.9 | 3.0 | 8.3 |
| Infusion Site Pain | 7.0 | 4.0 | 20.8 |
| Systemic: | |||
| Abdominal Pain | 4.7 | 3.0 | 4.2 |
| Constipation | 2.3 | 0.0 | 0.0 |
| Diarrhea | 11.7 | 17.0 | 4.2 |
| Loose Stools | 2.1 | 0.0 | 0.0 |
| Vomiting | 10.2 | 11.0 | 8.3 |
| Pyrexia | 4.9 | 6.0 | 8.3 |
| Upper Respiratory Tract Infection | 2.3 | 3.0 | 0.0 |
| Headache | 4.4 | 4.0 | 0.0 |
| Cough | 4.4 | 3.0 | 0.0 |
| Diaper Dermatitis | 4.7 | 4.0 | 0.0 |
| Rash | 2.9 | 2.0 | 8.3 |
Additional adverse experiences that were reported with Invanz with an incidence >0.5% within each body system are listed below:
Gastrointestinal Disorders: nausea
General Disorders and Administration Site Condition: hypothermia, chest pain, upper abdominal pain; infusion site pruritus, induration, phlebitis, swelling, and warmth
Infections and Infestations: candidiasis, oral candidiasis, viral pharyngitis, herpes simplex, ear infection, abdominal abscess
Metabolism and Nutrition Disorders: decreased appetite
Musculoskeletal and Connective Tissue Disorders: arthralgia
Nervous System Disorders: dizziness, somnolence
Psychiatric Disorders: insomnia
Reproductive System and Breast Disorders: genital rash
Respiratory, Thoracic and Mediastinal Disorders: wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea
Skin and Subcutaneous Tissue Disorders: dermatitis, pruritus, rash erythematous, skin lesion
Vascular Disorders: phlebitis.
Post-Marketing Experience
The following additional adverse reactions have been identified during the post-approval use of Invanz. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: anaphylaxis including anaphylactoid reactions
Musculoskeletal and Connective Tissue Disorders: muscular weakness
Nervous System Disorders: dyskinesia, myoclonus, tremor
Psychiatric Disorders: altered mental status (including aggression, delirium), hallucinations
Skin and Subcutaneous Tissue Disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Adverse Laboratory Changes in Clinical Trials
Adults Receiving Invanz as Treatment Regimen
Laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with Invanz in clinical trials are presented in Table 6. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, in clinical trials were ALT increased (6.0%), AST increased (5.2%), serum alkaline phosphatase increased (3.4%), and platelet count increased (2.8%). Invanz was discontinued due to laboratory adverse experiences in 0.3% of patients.
| Invanz† 1 g daily |
Piperacillin/ Tazobactam† 3.375 g q6h |
Invanz‡ 1 g daily |
Ceftriaxone‡ 1 or 2 g daily |
|
| Adverse laboratory experiences | (n§=766) | (n§=755) | (n§=1122) | (n§=920) |
|
||||
| ALT increased | 8.8 | 7.3 | 8.3 | 6.9 |
| AST increased | 8.4 | 8.3 | 7.1 | 6.5 |
| Serum alkaline phosphatase increased | 6.6 | 7.2 | 4.3 | 2.8 |
| Eosinophils increased | 1.1 | 1.1 | 2.1 | 1.8 |
| Hematocrit decreased | 3.0 | 2.9 | 3.4 | 2.4 |
| Hemoglobin decreased | 4.9 | 4.7 | 4.5 | 3.5 |
| Platelet count increased | 6.5 | 6.3 | 4.3 | 3.5 |
| Urine RBCs increased | 2.5 | 2.9 | 1.1 | 1.0 |
| Urine WBCs increased | 2.5 | 3.2 | 1.6 | 1.1 |
Additional laboratory adverse experiences that were reported during therapy in >0.1% of patients treated with Invanz in clinical trials include: increases in serum creatinine, serum glucose, BUN, total, direct and indirect serum bilirubin, serum sodium and potassium, PT and PTT; decreases in serum potassium, serum albumin, WBC, platelet count, and segmented neutrophils.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Invanz, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.
Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery
In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Invanz 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall laboratory adverse experience profile was generally comparable to that observed for Invanz in previous clinical trials.
Pediatric Patients Receiving Invanz as a Treatment Regimen
Laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with Invanz in clinical trials are presented in Table 7. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, in clinical trials were neutrophil count decreased (3.0%), ALT increased (2.2%), and AST increased (2.1%).
| Invanz | Ceftriaxone | Ticarcillin/ Clavulanate |
|
| Adverse laboratory experiences | (n†=379) | (n†=97) | (n†=24) |
| ALT Increased | 3.8 | 1.1 | 4.3 |
| AST Increased | 3.8 | 1.1 | 4.3 |
| Neutrophil Count Decreased | 5.8 | 3.1 | 0.0 |
Additional laboratory adverse experiences that were reported during therapy in >0.5% of patients treated with Invanz in clinical trials include: alkaline phosphatase increased, eosinophil count increased, platelet count increased, white blood cell count decreased and urine protein present.
TopSide Effects by Body System - for Healthcare Professionals
General
In general, the most common side effects associated with ertapenem have been considered mild to moderate and have included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).
Local
Local side effects have included infused vein complication (up to 7.1%), extravasation (up to 1.9%), and phlebitis/thrombophlebitis (up to 1.9%). Injection site induration and injection site pain have been reported in greater than 0.1% of patients. Tenderness and ecchymosis have also been reported.
Nervous system
In clinical trials, seizures were reported in 0.5% of patients. Patients with end-stage renal disease may be at a greater risk of developing seizures. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of ertapenem.
Nervous system side effects have included headache (up to 6.8%), altered mental status (includes agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, stupor; up to 5.1%), insomnia (3.2%), and dizziness (up to 2.1%). Syncope, seizure, tremor, hypesthesia, spasm, paresthesia, and vertigo have been reported in greater than 0.1% of patients. Cerebrovascular accident (greater than 0.5% and less than 1%) has been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Hallucinations, dyskinesia, myoclonus, and tremor have been reported during postmarketing experience.
Gastrointestinal
Gastrointestinal side effects have included diarrhea (up to 10.3%), nausea (up to 8.5%), abdominal pain (up to 4.3%), constipation (up to 4%), vomiting (up to 4%), acid regurgitation (up to 1.6%), dyspepsia (up to 1.1%), and oral candidiasis (up to 1.4%). Gastrointestinal hemorrhage, anorexia, flatulence, Clostridium difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis, and taste perversion have been reported in greater than 0.1% of patients. Small intestinal obstruction (2.1%), C difficile infection or colitis (1.7%), dry mouth (greater than 0.5% and less than 1%), and hematochezia (greater than 0.5% and less than 1%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Cardiovascular
Cardiovascular side effects have included chest pain (up to 1.5%), hypotension (up to 2%), hypertension (up to 1.6%), and tachycardia (up to 1.6%). Heart failure, hematoma, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, and subdural hemorrhage have been reported in greater than 0.1% of patients.
Respiratory
Respiratory side effects have included dyspnea (up to 2.6%), cough (up to 1.6%), pharyngitis (up to 1.1%), rales/rhonchi (up to 1.1%), and respiratory distress (up to 1%). Pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, and voice disturbance have been reported in greater than 0.1% of patients. Pneumonia (2.1%) and atelectasis (3.4%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing have been reported in greater than 0.5% and less than 1% of patients in the prophylaxis study.
Dermatologic
Dermatologic side effects have included rash (up to 2.5%), pruritus (up to 2%), and erythema (up to 1.6%). Sweating, dermatitis, desquamation, and urticaria have been reported in greater than 0.1% of patients. Cellulitis (1.5%) has been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) has been reported during postmarketing experience.
Hematologic
Hematologic side effects have included increased platelet count (up to 6.5%), decreased hemoglobin (up to 4.9%), decreased hematocrit (up to 3.4%), increased eosinophils (up to 2.1%), decreased segmented neutrophils (up to 1.5%), increased prothrombin time (up to 1.2%), decreased platelet count (1.1%), and decreased WBCs (up to 1.5%). Increased monocytes and PTT have been reported in greater than 0.1% and less than 1% of patients. Anemia (5.7%) and increased white blood cell count (greater than 1%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Genitourinary
Genitourinary side effects have included vaginitis (up to 3.3%), increased urine RBCs (up to 2.5%), increased urine WBCs (up to 2.5%), and increased urine epithelial cells (greater than 0.1% and less than 1%). Oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis, and have been reported in greater than 0.1% of patients. Urinary tract infection (3.8%), dysuria (1.1%), presence of urine protein (greater than 1%), and pollakiuria (greater than 0.5% and less than 1%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Hepatic
Hepatic side effects have included increased ALT (up to 8.8%), AST (up to 8.4%), and alkaline phosphatase (up to 6.6%).
Other
In clinical trials, death occurred in 1.6% of all patients (n=1954). In patients with intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving ertapenem; however, these were considered not drug-related.
Other side effects have included fever (up to 5%), edema/swelling (up to 3.4%), death (up to 2.5%), asthenia/fatigue (1.2%), and leg pain (up to 1.1%). Abdominal distention, pain, chills, septicemia, septic shock, malaise, necrosis, candidiasis, facial edema, flank pain, and flushing have been reported in greater than 0.1% of patients. Postoperative infection (2.3%), wound infection (6.5%), anastomotic leak (1.5%), seroma (1.3%), wound complication (2.9%), wound dehiscence (1.3%), and wound secretion (1.9%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication have been reported in greater than 0.5% and less than 1% of patients in the prophylaxis study.
Metabolic
Metabolic side effects have included decreased serum potassium (up to 1.8%), decreased serum albumin (up to 1.7%), increased serum glucose (up to 1.7%), increased serum bilirubin (up to 1.7%), increased serum potassium (up to 1.3%), dehydration (greater than 0.1%), and weight loss (greater than 0.1%). Increased direct and indirect serum bilirubin, increased serum sodium, and decreased serum bicarbonate have been reported in greater than 0.1% and less than 1% of patients.
Psychiatric
Psychiatric side effects have included anxiety (up to 1.4%). Nervousness, depression, and aggressive behavior have been reported in greater than 0.1% of patients. Altered mental status (including aggression, delirium) has been reported during postmarketing experience.
Renal
Renal side effects have included increased serum creatinine (up to 1.1%), renal insufficiency (greater than 0.1%), and increased BUN (greater than 0.1% and less than 1%).
Musculoskeletal
Musculoskeletal side effects have included gout (greater than 0.1%). Muscle spasms (greater than 0.5% and less than 1%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Hypersensitivity
Hypersensitivity side effects have included anaphylaxis (including anaphylactoid reactions) during postmarketing experience.
TopMore Invanz resources
- Invanz Prescribing Information (FDA)
- Invanz Concise Consumer Information (Cerner Multum)
- Invanz Monograph (AHFS DI)
- Invanz MedFacts Consumer Leaflet (Wolters Kluwer)
- Invanz Advanced Consumer (Micromedex) - Includes Dosage Information
- Ertapenem Professional Patient Advice (Wolters Kluwer)
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